Journal article
Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Vaccine, Vol.36(5), pp.606-614
01/29/2018
DOI: 10.1016/j.vaccine.2017.12.061
PMCID: PMC5777223
PMID: 29279281
Abstract
In older adults, prior administration of 23-valent pneumococcal polysaccharide vaccine (PPSV23) blunts the opsonophagocytic antibody (OPA) response to subsequent administration of 13-valent pneumococcal conjugate vaccine (PCV13). To determine whether a higher dose of PCV13 could mitigate this effect in adults 55 through 74 years of age, we compared OPA responses to a double dose of PCV13 in persons previously vaccinated with PPSV23 with responses to a single dose of PCV13 in previously vaccinated persons, and with a single dose in PPSV23 naïve persons.
Subjects previously vaccinated with PPSV23 were randomly assigned to receive either a single injection or two concurrent injections of 0.5 mL PCV13. Naïve subjects received a single injection of 0.5 mL PCV13. Serotype-specific OPA responses to 12 of the PCV13 serotypes were assessed on samples collected on Day 29 and Day 181. Comparisons of the OPA titers between study groups were based on the lower bound of the 95% confidence interval of the log geometric mean ratio to define superiority (>1) and non-inferiority (>0.5).
At Day 29, the OPA responses to one dose in previously vaccinated (n = 284) versus one dose in naïve subjects (n = 311) achieved the threshold for non-inferiority for only 3 of the 12 serotypes. In previously vaccinated subjects, responses to a double dose (n = 288) versus a single dose met the threshold for superiority for 7 serotypes. The responses to a double dose in previously vaccinated subjects versus a single dose in naïve subjects met the threshold for non-inferiority for 9 serotypes.
There is a dose response to PCV13 in older adults and the higher response to a double dose in previously vaccinated adults is non-inferior to that of a single dose in naïve adults for 9 of the 12 PCV13 serotypes evaluated.
Details
- Title: Subtitle
- Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
- Creators
- Lisa A. Jackson - Kaiser Permanente Washington Health Research InstituteHana M. El Sahly - Baylor College of MedicineSarah George - Saint Louis UniversityPatricia Winokur - Iowa City VA Medical CenterKathryn Edwards - Vanderbilt University Medical CenterRebecca C. Brady - Cincinnati Children's Hospital Medical CenterNadine Rouphael - Emory UniversityWendy A. Keitel - Baylor College of MedicineMark J. Mulligan - Emory UniversityRobert L. Burton - University of Alabama at BirminghamAya Nakamura - EmmesJennifer Ferreria - EmmesMoon H. Nahm - University of Alabama at Birmingham
- Resource Type
- Journal article
- Publication Details
- Vaccine, Vol.36(5), pp.606-614
- Publisher
- Elsevier Ltd
- DOI
- 10.1016/j.vaccine.2017.12.061
- PMID
- 29279281
- PMCID
- PMC5777223
- ISSN
- 0264-410X
- eISSN
- 1873-2518
- Language
- English
- Date published
- 01/29/2018
- Academic Unit
- Infectious Diseases; Medicine Administration; Internal Medicine
- Record Identifier
- 9984359797402771
Metrics
6 Record Views